Clinical Trials Directory

Trials / Completed

CompletedNCT04257032

A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood

Relative Bioavailability of Rosuvastatin (Part 1) and Dabigatran (Part 2) Given Alone and Together With BI 1323495 in Healthy Male Subjects (Open, Single-dose, Randomised, Two-period Crossover Design in Each Trial Part)

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Boehringer Ingelheim · Industry
Sex
Male
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

The main objectives of this trial are to investigate the relative bioavailabilities of rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and together with BI 1323495 (Test 1, Test 2) following oral administration.

Conditions

Interventions

TypeNameDescription
DRUGRosuvastatinTablet
DRUGRosuvastatin + BI 1323495Tablets
DRUGDabigatran etexilateCapsule
DRUGDabigatran etexilate + BI 1323495Capsule and tablets

Timeline

Start date
2020-02-13
Primary completion
2020-09-23
Completion
2020-09-23
First posted
2020-02-05
Last updated
2024-02-23
Results posted
2024-02-23

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT04257032. Inclusion in this directory is not an endorsement.